(198 days)
PowerLoc™ Max Power Injectable Infusion Set:
The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vasular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc™ Max Power Injectable Infusion Set is also indicated for power injection of contrast media. These devices may be used in any patient population with an implanted vascular port.
For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 gauge needles, and 2 mL/s for 22 gauge needles.
SafeStep™ Huber Needle Set:
The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
These devices may be used in any patient population with an implanted vascular port.
Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.
PowerLoc™ Max Power Injectable Infusion set is a non-coring Huber needle and infusion set with a manually activated needlestick prevention safety mechanism. These devices access surgically implanted subcutaneous vascular ports by penetrating the port septum to provide a closed fluid pathway for the infusion of fluids and drugs, as well as blood sampling. In addition, it may be used for power injection of contrast media through an implanted vascular port that is also indicated for power injection up to 325 psi (2241 kPa). It is supplied sterile and non-pyrogenic, for single use only.
The PowerLoc™ Max Power Injectable Infusion Set is offered with and without a Y-site.
SafeStep™ Huber Needle Set:
The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
These devices may be used in any patient population with an implanted vascular port.
Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.
This document describes the premarket notification for the "PowerLoc™ Max Power Injectable Infusion Set" and "SafeStep™ Huber Needle Set". The study presented focuses on demonstrating substantial equivalence to a predicate device (K171735) through performance testing, rather than a standalone clinical study to establish new acceptance criteria. Therefore, much of the requested information regarding clinical studies, expert-established ground truth, and training data is not applicable in this context.
Here's a breakdown of the available and applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implied by the "All testing passed the predetermined acceptance criteria" statement. Specific quantitative acceptance criteria or detailed performance results are not provided in this summary. Instead, the document lists the type of test conducted and the standard it references, indicating compliance.
| Test Category | Reference Standard / Test Description | Device Performance (as reported) |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process. Tests include Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Subchronic Systemic Toxicity, Hemocompatibility. | Passed, free from biological hazard, material acceptability confirmed by health-based risk assessment. |
| Assembly Burst | ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements. Test to confirm assembly burst pressure exceeds peak pressure at maximum flow conditions. | Passed (exceeded peak pressure). |
| Assembly Tensile | ISO 8536-4:2019 – Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed. Test to demonstrate peak tensile force of each assembly exceeds minimum peak tensile force. | Passed (exceeded minimum peak tensile force). |
| Assembly Air Leak | ISO 8536-10:2015 – Infusion equipment for medical use – Part 10: Accessories for fluid lines for single use with pressure infusion equipment. Test to confirm no leak when occluded. | Passed (no leak). |
| Assembly High Pressure Water Leak/Burst (2X) | ISO 8536-10:2015 – Infusion equipment for medical use – Part 10: Accessories for fluid lines for single use with pressure infusion equipment. Test to confirm PowerLoc™ Max does not leak or burst at maximum indicated flow rate. | Passed (no leak or burst at max indicated flow rate). |
| Assembly Occlusion/Flow Rate | ISO 7864:2016: Sterile hypodermic needles for single use – Requirements and test methods. Test to confirm minimum flow rates. | Passed (confirmed minimum flow rates). |
| Clamp Function | Internal Standard. Test to confirm fluids will not pass through tubing when the clamp is engaged. | Passed (no fluid passage when clamp engaged). |
| Luer Adapter Testing | ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications. Tests include Leak, Leak Decay, Stress Cracking, Resistance to Separation from Axial Load, Unscrewing, Overriding. | Passed (met all requirements). |
| Particulate Testing | USP : Sizing and Counting Particulate Matter. Test to ensure particulate matter on the catheter post-manufacture is not exceeded for prescribed particle sizes. | Passed (particulate matter levels not exceeded). |
| Needleless Y-Site Testing | Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)] (2008). Tests include Microbial Ingress, Valve Activation, Air Introduction Due to Device Connect/Disconnect. | Passed (met all requirements for SafeStep™ Huber Needle Set configurations with Y-site). |
| Residual Toxicity (Ethylene Oxide Residuals) | ISO 10993-7:2008: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals. Test to ensure EO residuals are below requirements for any patient with an implanted port. | Passed (EO residuals below required levels). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual performance test. It broadly states "All testing passed the predetermined acceptance criteria."
- Data Provenance: The studies were conducted "by or for Bard Access Systems (BD)". The data is presumably from laboratory testing, not patient data (retrospective or prospective), given the nature of the device and the tests performed. The country of origin for the data is not specified, but the applicant's address is in Salt Lake City, Utah, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device's substantial equivalence was established through engineering and performance testing against recognized standards, not through clinical trials requiring expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
This information is not applicable, as no clinical study with human observers or adjudication committees was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. This is a medical device (infusion set and Huber needle set), not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests would be the established requirements and limits defined by the referenced ISO standards, USP standards, and internal protocols for a device of this type. For example, for "Assembly Burst," the ground truth is that the device must withstand a certain pressure without bursting, as defined by ISO 10555-1.
8. The Sample Size for the Training Set
This is not applicable. There is no AI component or training set involved in the assessment of this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set. The "ground truth" for the device's acceptable performance is derived from established international and national standards for medical devices and internal quality control protocols.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).